Variable Negative External Pressure (vNEP) - An Alternative to Continuous Positive Airway Pressure (CPAP) for the Treatment of Obstructive Sleep Apnea (OSA): A Pilot Study

March 30, 2021 updated by: Somne, LLC

Non-compliance rates estimated at 50% pose a major issue for CPAP therapy, the primary treatment for OSA. Negative external pressure, applied over the anterior neck under the mandible, has shown encouraging results as an alternative therapy. This study assessed a variety of sizes and shapes of collars and a range of pressures for variable negative external pressure (vNEP) treatment in subjects having moderate OSA to identify combinations that improve the efficacy and comfort of this emerging therapy.

Observations made in this study may be used to plan a more definitive follow-on investigation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Leandro, California, United States, 94578
        • California Center for Sleep Disorders

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • a polysomnogram study or home sleep test within the previous six months that shows either an AHI > 15 and AHI <= 30
  • able, in the opinion of the investigator, to understand and comply with all study procedures
  • the vNEP collar is determined by the investigator to properly fit the subject and is well-tolerated after application to the neck.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: vNEP with various shapes and sizes and overnight PSG
Administer vNEP therapy to study participants on the throat's anterior surface with a variable negative pressure ranging from -20 cmH2O up to -35 cmH2O. Assess participants for a reduction in Apnea-Hypopnea Index (AHI) for at least 120 minutes using polysomnography (PSG) and treatment tolerance compared to CPAP.
Device: vNEP
Apply vNEP therapy to the anterior surface of the throat with a variable negative pressure ranging from -20 cmH2O up to -35 cmH2O and vNEP devices of varying shapes and sizes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete response
Time Frame: For 120 min
Decrease in AHI <=5
For 120 min
Response
Time Frame: For 120 min
Decrease in AHI of >=50% from baseline
For 120 min

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
No response
Time Frame: For 120 min
Did not achieve Primary Outcome Measure
For 120 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Somne, LLC

Collaborators

California Center for Sleep Disorders

Investigators

  • Principal Investigator: Jerrold Kram, MD, California Center for Sleep Disorders

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 19, 2020

Primary Completion (Actual)

March 15, 2021

Study Completion (Actual)

March 30, 2021

Study Registration Dates

First Submitted

January 14, 2021

First Submitted That Met QC Criteria

January 17, 2021

First Posted (Actual)

January 22, 2021

Study Record Updates

Last Update Posted (Actual)

April 2, 2021

Last Update Submitted That Met QC Criteria

March 30, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20193101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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